Senior Validation Engineer

BioSpace; Worcester (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to join their dynamic team in Worcester. This role involves validating biologics equipment in a regulated environment, ensuring compliance with safety and quality standards. The successful candidate will prepare validation protocols, mentor junior engineers, and drive continuous improvement projects. If you're passionate about making a significant impact in the biopharmaceutical field and enjoy working in a collaborative environment, this opportunity is perfect for you. Join a company committed to innovation and excellence in healthcare.

Benefits

Paid time off

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• 5+ years of experience in biologics manufacturing validation.
• Strong technical writing and organizational skills are required.
• Experience with continuous improvement practices is preferred.

Responsibilities

• Prepare and execute validation test protocols for capital projects.
• Mentor junior engineers and manage continuous improvement projects.
• Comply with regulatory and quality system procedures.

Skills

Validation of biologics equipment

Technical writing

Project management

Risk assessment

Interpersonal skills

GMP environment experience

Education

BS Degree in Engineering

Tools

Kaye Validator

Bioreactors

Distributed Control Systems

Process Logic Controllers

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.

The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and / or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA / GMP regulated environment. The engineer will work in a multi-disciplinary team environment.

Primary Responsibilities :

Prepare validation test protocols, set validation strategy, perform / coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze / assemble test results to create summary reports as required

Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management

Provide input on risk assessments and system classifications

Review new equipment specifications

Manage continuous improvement projects and drive to completion

Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification / validation test protocols

Work with appropriate departments and personnel to resolve validation testing issues

Advise other departments on SOPs related to validation projects

Maintain 100% on time training

Achieve Site, Department and Group performance metrics

Complete other special projects and assignments as required

Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs

Qualifications

Qualifications

Education :

BS Degree in engineering or technical discipline with a minimum of minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.

An understanding of basic unit operations involving cell culture and protein purification is required

Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required

Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is required

Experience with risk-based approach to commissioning and qualification preferred

Experience with temperature mapping of environmental chambers, autoclave validation is desired

Familiarity with distributed control systems and process logic controllers is required

Must have familiarity with P&IDs, loop diagrams, etc.

Must have hands-on experience on the Kaye Validator

Familiarity with project management is preferred

Experience with continuous improvement to streamline practices & procedures is preferred

Adherence to cGMP and GDP is required

Strong technical writing skill is required

Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred

Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously

Must demonstrate strong interpersonal & teamwork skills

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law :

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical / dental / visioninsurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note : No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

https : / / www.abbvie.com / join-us / reasonable-accommodations.html

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Validation Engineer • Worcester, MA, United States